Kornimate/medical-research-clean huggingface dataset:
observational study with antiretroviral treated patients switching to nevirapine plus two nucleoside reverse transcriptase inhibitor (nrti) regimens

Conditions: HIV Infections

Summary: collecting data on maintaining anti-retroviral activity (quantitative hiv rna determination) and immunological activity (cd4 cells) after switching from protease inhibitor or nnrti to nevirapine (viramune®) and collecting of routinely observed laboratory data on lipids, and liver enzymes.


Eligibility criteria:
inclusion criteria: * patients suffer from hiv type 1 infection * patient is treated with antiretroviral protease-inhibitors or non-nucleoside reverse transcriptase inhibitors * patient has shown a depression of viral load before limit of detection (\< 50 hiv-rna copies/ml) for more than 6 months prior to visit 1 * patient is male or female with age greater than or equal to 18 years * women have to be willing to use an effective barrier method of contraception for the duration of the observational study participation exclusion criteria: * patient has clinically relevant laboratory findings (e.g., aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> five times upper limit of normal (uln)) * patients is hypersensitive to viramune® or to any of its excipients * patient is not able to abstain from treatment with ketoconazole, oral contraceptives, or other drug affecting cyp3a-metabolism * patients is breast-feeding * patient is pregnant * patient is a woman and does not use effective contraception
spironolactone versus prednisolone in dmd

Conditions: Muscular Dystrophy, Duchenne

Summary: this is a randomized, open-label, pilot clinical trial of spironolactone suspension versus oral prednisolone for use in duchenne muscular dystrophy. the goals are to determine the safety of 6 months of treatment with spironolactone treatment int he steroid-naive dmd population as well as to determine if either spironolactone or a standard clinical dose of corticosteroids results in equivalent improvement in time to complete the 100 meter timed test (100m).

until recently, the only treatment shown to improve strength and preserve ambulation in dmd patients was the use of glucocorticoids, which are accompanied by significant side effects including obesity, cushingoid features, osteoporosis, and behavioral disturbances. spironolactone is an aldosterone antagonist primarily used as a potassium sparing diuretic that is widely used in the pediatric population, with limited side-effects including gynecomastia and hyperkalemia. recent studies by dr. rafael-fortney have evaluated the effect of spironolactone treatment in several different mouse models of dmd. her results show that treatment of these mice demonstrates increased muscle membrane stabilization while reducing the negative side-effects typically associated with standard of care glucocorticoids. this pilot study is designed to determine whether this commonly used medication, spironolactone, may have similar beneficial effects with a lower side effect profile and be applicable to a wider population of dmd patients. the hypothesis for this controlled pilot trial is that spironolactone and prednisolone are of equal efficacy in improving skeletal muscle function over a 6-month period, and that spironolactone will be well tolerated in this patient population. one outcome is that both drugs demonstrate equal efficacy in motor function. this would then serve as pilot data for a longer term study.

Eligibility criteria:
inclusion criteria: * duchenne muscular dystrophy (dmd) patients ≥4 to ≤7 years of age * clinical features of dmd that include proximal predominant weakness and/or gait disturbance * presence of a truncating mutation of the dmd gene in the patient or an affected male relative or a muscle biopsy that demonstrates \<5% dystrophin in the patient or an affected male relative * normal left ventricular ejection fraction by screening echocardiogram * ability to cooperate for testing * no prior treatment with glucocorticoids or vamorolone * no concomitant experimental therapies exclusion criteria: * subject amenable to or currently being treated with eteplirsen, casimersen, or viltolarsen * hyperkalemia at screening * history of or ongoing renal failure (elevated creatinine, oliguria, anuria) * hypersensitivity to spironolactone (rash, respiratory distress, arrhythmia, numbness or tingling of extremities) * current treatment with an acei * severe peptic ulcer disease or recent gastrointestinal perforations
comparison of sms and ivr surveys in tanzania

Conditions: Surveys and Questionnaires; Noncommunicable Diseases

Summary: this study focuses on mechanisms to adapt the performance of interactive voice response (ivr) and short message service (sms) surveys conducted in low-and middle-income (lmic) setting (tanzania) and evaluates how the two survey modalities (ivr and sms) affect survey metrics, including response, completion and attrition rates.

using random digit dialing (rdd) sampling technique, participants will be randomized to one of two arms : 1) ivr or 2) sms. participants in the first study arm will receive an ivr survey. participants in the second study arm will receive a sms survey. the ivr and sms questionnaires contain a set of demographic questions and one non-communicable disease (ncd) module (alcohol, or tobacco, or diet, or physical activity, or blood pressure and diabetes). we will examine contact, response, refusal and cooperation rates and demographic representativeness by each study arm.

Eligibility criteria:
inclusion criteria: * access to a mobile phone * greater or equal to 18 years of age * conversant in the swahili language exclusion criteria: * less than 18 years of age

Keywords: mobile phone surveys interactive voice response short message service
pharmacokinetics of itraconazole in pediatric cancer patients

Conditions: Pediatric, Cancer

Summary: this study investigated repeated-dose pharmacokinetics and safety of itraconazole and its active metabolite hydroxyitraconazole in pediatric cancer patients at risk for the development of invasive fungal disease.


Eligibility criteria:
inclusion criteria: * pediatric patients who are under chemotherapy, and receive itraconazole. exclusion criteria: 1. patients with significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases. * heart : fractional shortening \< 30%, ejection fraction \< 45% * liver : total bilirubin ≥ 2 x upper limit of normal (uln) ; aminotransferase ≥ 3 x uln * kidney : creatinine ≥ 2 x normal or gfr ≤ 60㎖/min/1.73㎡ 2. patients with hypersensitivity to azoles. 3. patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study. 4. pregnant or nursing women. 5. psychiatric disorder that would preclude compliance.

Keywords: pediatric cancer invasive fungal disease antifungal agent
a phase i maximum tolerated dose study of ci-1012 in late-stage hiv+ patients

Conditions: HIV Infections

Summary: to determine the maximum tolerated dose of ci-1012 in late-stage hiv-1-infected patients. to determine the antiretroviral activity of ci-1012 when added to combination therapy. to assess the multiple-dose pharmacokinetic characteristics of ct-1012 when added to combination therapy. to assess the effect of ci-1012 on the pharmacokinetics of other antiretroviral agents.

doses are escalated based on safety assessments: as soon as a dose meets the criteria for "tolerated" or "not tolerated", doses are escalated or terminated, respectively. all patients are treated for 2 weeks, with follow-up visits scheduled 1 week and 1 month post-treatment.

Eligibility criteria:
inclusion criteria patients must have: * serological evidence of late-stage hiv-1 infection (elisa and western blot). * cd4 t cell count less than or equal to 200 mm3. * hiv-1 rna greater than or equal to 5,000 copies/ml. exclusion criteria prior medication: excluded: * anti-hiv treatment within 8 weeks prior to entry. * systemic steroids within 4 weeks prior to entry. prior treatment: excluded: treatment with anticancer agents within 4 weeks prior to study.

Keywords: hiv-1 dose-response relationship, drug anti-hiv agents
neoadjuvant radiosurgery for resectable brain metastases: phase i/ii study

Conditions: Tumors Metastatic to Brain

Summary: this phase i/ii trial studies the ability to stop brain metastases from coming back after treatment with radiosurgery followed by surgical resection. it will also evaluate the side effects of these combined treatments and help determine the best radiosurgery dose. radiosurgery focuses the x-rays directly to the tumor and cause less damage to the normal tissue in the brain.

primary objectives: i. to determine the safety (risk of acute and long-term toxicities) of neoadjuvant radiosurgery at escalating doses followed by surgical resection of brain metastases. (phase i) ii. to determine the local control of brain metastases treated with neoadjuvant radiosurgery followed by surgical resection. (phase ii) secondary objectives: i. to determine the rate of distant brain failure when brain metastases are managed with neoadjuvant radiosurgery followed by surgical resection. ii. to estimate the rate of salvage surgery, whole brain radiation therapy (wbrt), or stereotactic radiosurgery (srs) for participants treated with neoadjuvant radiosurgery followed by surgical resection. iii. to determine the rate of radiation necrosis/steroid dependency. iv. to determine the radiobiologic impact of neoadjuvant radiosurgery for resected brain metastases. outline: this is a phase i, dose-escalation study of radiosurgery followed by a phase ii study. the following outcomes were removed from the protocol in an amendment: * changes in neurocognitive function as measured by the hopkins verbal learning test (hvlt), controlled oral word association (cowa) \& trailmaking test b, and trailmaking test a * qol measured by fact-br and eortc-qlq30

Eligibility criteria:
inclusion criteria: * have a prior histologic diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies * magnetic resonance imaging (mri) evidence of 1-4 brain metastases, with at least one lesion \> 20 mm and ≤ 50 mm in maximal diameter and determined to be appropriate for srs and gross total resection; all other brain metastases are appropriate for srs * patient can have prior srs to lesions other than the one planned for neoadjuvant srs and resection * patient must have a karnofsky performance score of ≥ 70 exclusion criteria: * patient deemed medically unfit to undergo surgical resection of brain metastasis * prior whole brain radiotherapy * patient with contraindication for imaging with mri * inability to participate in study activities due to physical or mental limitations * inability or unwillingness to return for all the required follow-up visits * at the time of planning, unable to deliver 10 gray (gy) or less to optic nerve/chiasm * tumor located in the brainstem * imaging or cytologic evidence of leptomeningeal disease
endovascular therapy combined with tirofiban for intracranial atherosclerotic acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: this randomized controlled trial aims to evaluate whether adjunctive tirofiban therapy combined with endovascular treatment (evt) improves neurological outcomes in patients with acute large vessel occlusion due to large-artery atherosclerosis. patients will be randomized to receive either tirofiban or matching placebo after evt. the primary efficacy endpoint is the proportion of patients achieving functional independence (modified rankin scale 0-2) at 90±7 days, while the safety endpoint is the probability of symptomatic intracranial hemorrhagewithin 48 hours after randomization.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. pre-stroke modified rankin scale (mrs) score of 0-1 3. acute ischemic stroke symptoms present within 24 hours of last known well time 4. baseline national institutes of health stroke scale (nihss) score ≥6 5. anterior circulation: alberta stroke program early ct score (aspects) ≥6 posterior circulation: pc-aspects ≥6 6. occlusion of intracranial internal carotid artery (ica), m1 segment of middle cerebral artery (mca), v4 segment of vertebral artery, or basilar artery 7. clinical care team plans to perform endovascular thrombectomy (evt) 8. subject or legally authorized representative can provide informed consent 9. residual stenosis ≥50% without planned angioplasty/stenting exclusion criteria: 1. intracranial hemorrhage confirmed by imaging prior to randomization, or major intracranial hemorrhage on intraprocedural flat-panel ct 2. gastrointestinal or genitourinary bleeding within 30 days post-stroke onset, or major surgery within 14 days 3. bleeding diathesis including coagulopathy (platelets \ 50s, or inr \>2.0), doac use within 48 hours, or history of hit 4. pregnancy or lactation at admission 5. contraindications to radiographic contrast agents, nickel, titanium or their alloys 6. life expectancy \<6 months 7. pre-existing neurological/psychiatric conditions that may confound assessment 8. severe renal insufficiency (gfr \ 220μmol/l \[2.5mg/dl\]) 9. arterial tortuosity or anomalies preventing device delivery 10. unlikely to complete 90-day follow-up 11. any confirmed cardioembolic source (including atrial fibrillation, valvular disease, intracardiac thrombus, recent mi, cardiomyopathy with ef \<30%, etc.) 12. tirofiban or other gp iib/iiia inhibitor use before randomization or other gp iib/iiia inhibitor used post treatment

Keywords: acute ischemic stroke tirofiban placebo randomized controlled trial intracranial atherosclerotic
life satisfaction and psychopathology in institutionalized elderly people

Conditions: Anxiety Depression (Mild or Not Persistent)

Summary: the present study attempted to test the benefits of a mindfulness-based stress reduction (mbsr) program in portuguese institutionalized elderly people, as a way to improve life satisfaction and reduce psychopathology. the sample included 12 institutionalized elderly people, with ages between 65 and 91 (m = 82.58 years; sd = 7.87), that filled several selfreport questionnaires and were assessed with mini mental state examination. participants attended to an adapted mindfulness-based stress reduction program (kabatzinn,1994), with 48 sessions (16 weeks) and participants were evaluated before and after the intervention.


Eligibility criteria:
inclusion criteria: * literacy * age above 65 years exclusion criteria: * presence of cognitive or sensorial * impairment

Keywords: mindfulness elderly psychopathology
preloading magnesium attenuate cisplatin-induced nephrotoxicity

Conditions: Acute Kidney Injury

Summary: the purpose of this study is to determine whether magnesium preloading reduce incident of cisplatin induced acute kidney injury in head and neck cancer who receiving low dose cisplatin (40 mg/m2 weekly for 7 weeks).

randomized controlled trial comparing efficacy of magnesium preloading versus normal saline for prevention of acute and chronic nephrotoxicity of cisplatin.

Eligibility criteria:
inclusion criteria: * age \> 18 years * eastern cooperative oncology group score 0-2 * first diagnosed head and neck cancer and plan for treatment with cisplatin * serum creatinine ≤1.5 mg/dl or egfr≥60(ml/min/1.73 m2) exclusion criteria: * prior treatment with cisplatin before randomization * uncontrolled concurrent disease * pregnancy

Keywords: cisplatin nephrotoxicity acute kidney injury
boston early-onset chronic obstructive pulmonary disease (copd) study

Conditions: Chronic Obstructive Pulmonary Disease

Summary: chronic obstructive pulmonary disease (copd) is often caused by cigarette smoking, but genetic predisposition also influences copd susceptibility. the purpose of this study is to identify genetic factors that predispose some individuals to develop copd.

chronic obstructive pulmonary disease (copd), which is the third leading cause of death in the united states, affects millions of people around the world. copd, which can include both emphysema and chronic bronchitis, affects the lungs making it very difficult to breathe. cigarette smoking is the most common risk factor for developing copd; however, only 15% to 20% of smokers develop copd in their lifetimes. the onset of copd also varies greatly from person to person; while some people do not develop respiratory symptoms until later in life, there are others who develop severe copd at a very early age. prior research has led to the discovery of the alpha-1 antitrypsin protein deficiency in association with copd development. this discovery has generated further interest toward studying other genetic factors which may also affect an individual's likelihood of developing copd. therefore, the purpose of the boston early-onset copd study is to gain a better understanding of copd risk factors in order to establish new possible methods of treatment for people affected by copd. for this study we are enrolling individuals affected with severe copd (52 years old or younger with an fev1 \< 40%) and their family members. each participant will attend one study visit that involves a respiratory questionnaire, a breathing test, and blood draw. this visit can be completed at the participant's home, in the hospital, or by long distance data collection (phone interview, local breathing tests, and local blood draw with mailed samples), whichever is preferred.

Eligibility criteria:
inclusion criteria for early-onset copd probands: * early onset of copd in individuals younger than 53 years old * spirometry results that are indicative of severe copd (fev1 \< 40% predicted) * physician-diagnosed copd exclusion criteria for early-onset copd probands: * severe alpha-1 antitrypsin deficiency * other chronic lung diseases in participants with copd (except asthma) * pregnant * any previous lung surgery including lung transplant or lung reduction volume surgery (lvrs); unless prior pulmonary function tests are available

Keywords: chronic obstructive pulmonary disease copd emphysema chronic bronchitis genetics association studies
efficacy and satisfaction comparing two braces in the treatment of developmental dysplasia of the hip (ddh) in infants

Conditions: Hip Dislocation, Congenital; Congenital Deformity of Hip Joint

Summary: the purpose of this study is to 1) evaluate the effectiveness of the plastizote abduction brace compared to the pavlik harness in the treatment of developmental dysplasia of the hip (ddh) and 2) compare parent/caregiver satisfaction between the plastizote abduction brace and the pavlik harness. the investigators hope to learn which brace treatment is best for a definable population so the appropriate brace can be chosen initially avoiding the time, expense, and frustration of a failed technique.


Eligibility criteria:
inclusion criteria: 1. 0-2 months of age 2. nonterratological developmental dysplasia of the hip diagnosed by physical exam and standard of care ultrasound exclusion criteria: 1. ages greater than 2 months 2. neurological condition 3. terratological congenital dysplasia of the hip diagnosed by physical exam and standard of care ultrasound 4. chromosomal abnormality
assertive community treatment (act) in schizophrenia spectrum disorders

Conditions: Schizophrenia

Summary: the study examined the 12-month effectiveness of continuous therapeutic assertive community treatment (act) as part of integrated care (ic) compared to standard care (sc) in a catchment area comparison design in patients with schizophrenia spectrum disorders (ssd) treated with quetiapine ir.

two catchment areas in hamburg, germany with similar population size and health care structures were assigned to offer 12-month act (\& ic; department of psychiatry and psychotherapy, university medical center hamburg-eppendorf) or sc (asklepios hospital, department of psychiatry and psychotherapy) to 120 first-episode and negatively selected multiple-episode patients with ssd. primary outcome was the time to service disengagement. secondary outcomes comprised medication non-adherence, improvements of symptoms, functioning, quality of life, satisfaction with care from patients and relatives perspectives, and service use data.

Eligibility criteria:
inclusion criteria: * age 18-65 years * met the diagnostic criteria of a first- or multiple episode of a schizophrenia spectrum disorders, i.e. schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, or psychotic disorder nos * new initiation or current treatment with quetiapine immediate release (ir) exclusion criteria: * other psychotic disorders (e.g., due to medical condition) * mental retardation (iq lower than 70 points)

Keywords: schizophrenia, assertive community treatment, quetiapine
the randomized controlled clinical trial of kushen injection

Conditions: Lung Cancer

Summary: the randomized controlled multicenter clinical study of compound kushen injection to reduce the radiotherapy related adverse reactions in lung cancer is a phase ⅳ clinical trials，the main purpose is to evaluate the effect of compound kushen injection in preventing and reducing the radiotherapy related adverse reactions. the participants of the clinical trials are patients with lung cancer who need thoracic radiotherapy. in clinical trials, one group of participants is given compound kushen injection with chemoradiotherapy, while another group is only given chemoradiotherapy. the period of trials is 18 months.

patients with lung cancer who need thoracic radiotherapy will be enrolled in the trial, then seprated randomly in two group,the ks injection group treated with chemoradiotherapy plus ks injection; the contral group treated with chemoradiotherapy only. after 6 months observation, the rates of incidence and the degree of adverse reactions caused by redioterapy; the completion rate of radiotherapy; clinical symptoms; qof and pulmonary function tests etc. will be evaluated.

Eligibility criteria:
inclusion criteria: * before the start of the study, all patients have been fully understood the reseach and the must sign the informed consent * to be aged from 18 to 75 years old, both gender * the lung cancer diagnosis must be proved by pathology * according to recist (version 1.1), at least 1 objectively measurable tumor lesion (iconography: ct, mri), the assessable lesion can be measured accurately, maximum diameter more than at least 10mm (malignant lymph nodes on ct scans short diameter less than at least 15 mm) * eastern cooperative oncology group (ecog) performance status less than or equal to 2 * lung function fev1 more than at least 1land more than 50% a normal value * the function of each organ is basically normal :anc more than 1.5\*10\^9/l, platelet count more than 100\*10\^9/l, hb more than 9.0g/dl, bil at normal level or less than 1.5\*uln, ast (sgot), alt (sgpt) less than 2.5\*uln(less than 5\*uln, if with liver metastases), scr less than 1.5\*uln * the expected survival tme must more than 6 months. exclusion criteria: * lung or mediastinal have received radiotherapy before or ever treated with compound kushen injection within 2weeks * pregnancy or lactation women * patients with severe, uncontrolled organic lesions or infection, such as decompensated heart, lung, kidney failure can lead to tolerance of chemotherapy - participating or within the last 30 days participated in other clinical trials * hypersensitiveness to any kind of trial regime * had a history of serious psychological or psychiatric disorders, drug addiction or alcohol dependence * estimating the compliance of patients to participate in this clinical trial is insufficient.

Keywords: radiotherapy adverse effect dermatitis or eczema